MiniMed Paradigm REAL-Time Revel
System
MiniMed Paradigm REAL-Time Revel System

MiniMed Paradigm REAL-Time Revel System

The world's only system to combine insulin pump therapy with continuous glucose monitoring. Insulin pump therapy combined with continuous glucose monitoring provides the information, convenience, and control to improve diabetes management.

How It Works

The MiniMed Paradigm® REAL-Time Revel System combines continuous glucose monitoring with an insulin pump. The MiniMed Paradigm REAL-Time Revel System allows people with diabetes the ability to see their glucose patterns and gives them the tools to react quickly.

A wireless transmitter sends information from a glucose sensor to the glucose monitor for readings every 5 minutes, 24 hours a day. Users specify the amount of insulin they want the pump to deliver based on the readings and their meals.

Paradigm REAL-Time insulin pump features

Paradigm REAL-Time Revel System

Glucose sensor and transmitter from insulin pump

Glucose sensor and transmitter

REAL Insights With Glucose Sensors

  • Inserts under the skin in a virtually painless process
  • Measures current glucose levels every 5 minutes, 24 hours a day
  • Fingersticks are required to calibrate the glucose sensor and before making treatment decisions

REAL-Time Readings

  • 60% of lows may be missed by fingerstick testing1
  • Glucose readings updated every 5 minutes, 24 hours a day
  • Increases glycemic awareness and promotes proactive control1-3
CGM-graph

Get far more useful information than just fingerstick testing alone with 24 hour glucose monitoring.


REAL-Time Trend Information

  • Trend arrows show the direction and rate of glucose level changes, enabling preventative action
  • Enables users to address even brief fluctuations in glucose levels. This can impact the development of long-term diabetes complications, such as eye, nerve, kidney and heart disease4,5
  • Trend graphs reveal the effects of diet, exercise, insulin, and medication on glucose levels
  • Works with CareLink® Software for online data management and retrospective analysis

REAL-Time Alerts

  • With the use of predictive alerts, hypoglycemic event detection improved by 36% compared to the low glucose alert alone 6-8
  • Warn of low and high glucose levels that fingersticks or A1C testing alone may not reveal9
  • Result in significant reduction in duration of hypoglycemic events9
Reduction in hypoglycemic events with continuous glucose monitor alerts

Patient response to REAL-Time Alarms resulted in a 48% reduction in mean duration of hypoglycemic excursions (from 64.4 minutes to 33.6 minutes)9

REAL Innovations

  • Easy-to-use menu navigation
  • Millions of safety checks for safe, reliable use
  • Downloadable continuous glucose trend histories from the user's pump onto a computer
  • Insights can help fine-tune basal rates and other settings for efficient therapy optimization1-3

BOLUS Wizard® Calculator

  • Calculates required insulin dose for meals and hyperglycemic corrections
  • Uses personal settings, blood glucose reading, carbohydrate reading, and active insulin inside the body to suggest a bolus amount
  • Reduces math errors, improves dosage accuracy, and avoids hypoglycemia after meals10
Bolus Wizard menu for insulin pump

Bolus wizard menu for insulin pump

REAL Comfort

  • Worn on belt, or under clothing
  • Tiny and discreet
  • Easy and painless glucose sensor insertion
Insulin pump being worn on belt

The insulin pump can be worn on a belt and under clothing

See the clinical benefits of insulin pump therapy.  

Includes

The MiniMed Paradigm REAL-Time System includes these components:

Indications for Use

The insulin pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons of all ages requiring insulin. The REAL-Time Continuous Glucose Monitoring components of the MiniMed Paradigm REAL-Time Revel Insulin Pump and Continuous Glucose Monitoring System are indicated to record interstitial glucose levels in persons seven years of age or older who have Type 1 or Type 2 diabetes. This information is intended to supplement, not replace, blood glucose information obtained using standard home blood glucose monitoring devices. A separate pediatric model is indicated for patients ages 7-17.  

Contraindications

Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day and to maintain contact with their healthcare professional. 

Successful operation of an insulin pump requires good vision and hearing. While features exist to help facilitate pump usage, Medtronic Diabetes does not recommend the use of this product by individuals whose impaired vision or hearing does not allow full recognition of the pump signals and alarms. 

Warnings/Precautions/Adverse Reactions 

Insulin pump therapy uses only faster-acting insulin. Therefore, any interruption in insulin delivery (due to infusion set clogs, loss of insulin potency, or pump malfunction) may result in hyperglycemia (high blood glucose) within 2 to 4 hours and, subsequently, the rapid onset of diabetic ketoacidosis (DKA) within 4 to 10 hours. Always carry an "emergency kit" of supplies that includes insulin, syringes or pens, blood glucose test strips and meter and urine ketone test strips, in case you develop a problem with your pump and your insulin delivery is stopped, or in case of high blood glucose. The onset of stress or illness (caused by infection or an emotional event) can also result in a rise of blood glucose levels and the development of DKA.

The intensive management of diabetes has also been associated with an increased incidence of hypoglycemia (low blood glucose). Never go to bed with a blood glucose value below your target level. Blood glucose tests should be performed before driving a vehicle or operating machinery, because hypoglycemia can have serious consequences.

The REAL-Time Continuous Glucose Monitoring components of the MiniMed Paradigm REAL-Time Revel Insulin Pump and Continuous Glucose Monitoring System are indicated to record interstitial glucose levels in persons 7 years of age or older who have Type 1 or Type 2 diabetes. This information is intended to supplement, not replace, blood glucose information obtained using standard home blood glucose monitoring devices.

Establish a plan with your healthcare professional for rapidly identifying and treating both hypoglycemia and hyperglycemia, to prevent the onset of DKA and possible hospitalization. Act quickly to respond to out-of-target blood glucose. Notify your healthcare professional of low blood glucose requiring assistance or of high blood glucose, or of an increased frequency in low or high blood glucose.

For complete safety information, including contraindications, warnings/complications, and potential complications, see product label or visit the Indications, Safety, and Warnings page.

References

  1. Kaufman FR, Gibson LC, Halvorson M, et al. A pilot study of the continuous glucose monitoring system: clinical decisions and glycemic control after its use in pediatric type 1 diabetic subjects. Diabetes Care. 2001;24(12):2030-2034.
  2. Bode BW, Gross TM, Thornton KR, et al. Continuous glucose monitoring used to adjust diabetes therapy improves glycosylated hemoglobin: a pilot study. Diabetes Res Clin Pract. 1999;46:183-190.
  3. Ludvigsson J, Hanas R. Continuous subcutaneous glucose monitoring improved metabolic control in pediatric patients with type 1 diabetes: a controlled crossover study. Pediatrics. 2003;111(5 Pt 1):933-938.
  4. Derr R, Garrett E, Stacy G, et al. Is HbA1C affected by glycemic instability? Diabetes Care. 2003;26(10):2728-2733.
  5. Lifetime benefits and costs of intensive therapy as practiced in the diabetes control and complications trial. The Diabetes Control and Complications Trial Research Group. JAMA. 1997;277(5):374-375.
  6. In this internal home-use study, the predicted alert was set at 30 minutes and the low threshold was set at 70mg/dL. The performance is calculated using a +/- 30 minute event analysis on 90,472 readings paired with sensor readings.
  7. Keenan B, Cartaya R, Mastrototaro J. Accuracy of a new real-time continuous glucose monitoring algorithm. J Diabetes Sci Technol. 2010;4(1):111-118.
  8. Mastrototaro J, Shin J, Marcus A, Sulur G. The accuracy and efficacy of real-time continuous glucose monitoring sensor in patients with type 1 diabetes. J Diabetes Sci Technol. 2007;(3):400-404.
  9. Bode BW, Gross K, Rikalo N, et al. Alarms based on real-time sensor glucose values alert patients to hypo- and hyperglycemia: the guardian continuous glucose monitoring system. Diabetes Technol Ther.  2004;6(2):105-113.
  10. Gross TM, Kayne D, King A, et al. A bolus calculator is an effective means of controlling postprandial glycemia in patients on insulin pump therapy. Diabetes Technol Ther. 2003;5(3):365-369.
Last updated: 24 Jan 2012

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